FDA Approves Evolocumab (Repatha) for Certain Patients with Hypercholesterolemia

Following a June 2015 recommendation by the U.S Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee, the FDA has approved evolocumab for use in addition to diet and maximally-tolerated statin therapy in adult patients with heterozygous familial hypercholesterolemia (HeFH), homozygous familial hypercholesterolemia (HoFH), or clinical atherosclerotic cardiovascular disease, such as heart attacks or strokes, who require additional lowering of LDL cholesterol. Evolocumab is produced by Amgen, and known by the brand name Repatha.

In the press release from the FDA, the FDA states that “the efficacy and safety of Repatha were evaluated in one 52-week placebo-controlled trial and eight 12-week placebo-controlled trials in participants with primary hyperlipidemia, including two that specifically enrolled participants with HeFH and one that enrolled participants with HoFH. In one of the 12-week studies, 329 participants with HeFH, who required additional lowering of LDL cholesterol despite statins with or without other lipid-lowering therapies, were randomized to receive Repatha or placebo for 12 weeks. Participants taking Repatha had an average reduction in LDL cholesterol of approximately 60 percent, compared to placebo.”

Repatha is the second drug in its class to be approved in the United States. The FDA approved alirocumab (praluent), produced by Sanofi and Regeneron in July.

Click here to read the FDA press release.